CAJ | 학술논문

背景与目的:PF方案是治疗晚期头颈部癌包括晚期鼻咽癌的标准方案,近年发现泰素帝加PF的TPF方案可提高其疗效.本研究旨在探讨TPF诱导化疗治疗晚期鼻咽癌的剂量限制毒性(dose-limitiong toxicity.DLT)和最大耐受剂量(maximum tolerated dose,MTD),同时观察疗效.方法:从2006年12月至2008年5月,共有41例初诊局部晚期(UICC分期Ⅲ、Ⅳ期)鼻咽癌患者人组,其中男性29例,女性12例,中位年龄47岁(29～60岁),ECOG体力状况评分≤2.TPF方案起始剂量为泰素帝40 mg/m~2 d1,顺铂40 mg/m~2 d1,氟尿嘧啶400 mg/m~2 d1～5,每3周重复,共2个周期.泰素帝和顺铂每剂量级增加5 mg/m~2,氟尿嘧啶增加50 mg/(m~2·d).每个剂量组至少收治6例患者,6例患者全部完成2个疗程化疗后并进行不良反应评价再进行剂量升级.第5周开始放射治疗,鼻咽原发病灶68～72 Gy/34～36次,7周,颈部淋巴结阳性区60～66 Gy/30～33次,6～6.5周.结果:41例患者共完成80周期化疗.40例(79个疗程)可评价疗效和不良反应.第1～4剂量组均未出现DLT;第5剂量组有3例出现DLT,包括3例持续超过1周的Ⅲ～Ⅳ度中性粒细胞减少,其中2例合并Ⅲ度口腔黏膜反应而使放疗终止超过1周;按照第5组剂量重新入组3例(第6组)并常规G-CSF支持治疗,1例出现不超过1周的短暂Ⅳ度中性粒细胞减少和Ⅲ度黏膜反应,未发现DLT;第7组4例均出现DLT,包括3例Ⅳ度中性粒细胞降低,其中1例合并发热及肺部感染,3例Ⅲ度腹泻,1例Ⅲ度黏膜反应持续10 d.至此终止剂量升级,按照第5剂量组继续治疗3例(第8组)均未发现DLT.全组未出现严重肝肾功能损伤,其他严重反应包括1例Ⅲ度贫血,4例Ⅲ度呕吐,9例Ⅲ度体重下降.结论:TPF方案是治疗晚期鼻咽癌的安全有效方案,推荐剂量为泰素帝60mg/m~2 d1,DDP 60 mg/m~2 d1.5-FU 600 me/m~2 d1～5.
배경여목적:PF방안시치료만기두경부암포괄만기비인암적표준방안,근년발현태소제가PF적TPF방안가제고기료효.본연구지재탐토TPF유도화료치료만기비인암적제량한제독성(dose-limitiong toxicity.DLT)화최대내수제량(maximum tolerated dose,MTD),동시관찰료효.방법:종2006년12월지2008년5월,공유41례초진국부만기(UICC분기Ⅲ、Ⅳ기)비인암환자인조,기중남성29례,녀성12례,중위년령47세(29～60세),ECOG체력상황평분≤2.TPF방안기시제량위태소제40 mg/m~2 d1,순박40 mg/m~2 d1,불뇨밀정400 mg/m~2 d1～5,매3주중복,공2개주기.태소제화순박매제량급증가5 mg/m~2,불뇨밀정증가50 mg/(m~2·d).매개제량조지소수치6례환자,6례환자전부완성2개료정화료후병진행불량반응평개재진행제량승급.제5주개시방사치료,비인원발병조68～72 Gy/34～36차,7주,경부림파결양성구60～66 Gy/30～33차,6～6.5주.결과:41례환자공완성80주기화료.40례(79개료정)가평개료효화불량반응.제1～4제량조균미출현DLT;제5제량조유3례출현DLT,포괄3례지속초과1주적Ⅲ～Ⅳ도중성립세포감소,기중2례합병Ⅲ도구강점막반응이사방료종지초과1주;안조제5조제량중신입조3례(제6조)병상규G-CSF지지치료,1례출현불초과1주적단잠Ⅳ도중성립세포감소화Ⅲ도점막반응,미발현DLT;제7조4례균출현DLT,포괄3례Ⅳ도중성립세포강저,기중1례합병발열급폐부감염,3례Ⅲ도복사,1례Ⅲ도점막반응지속10 d.지차종지제량승급,안조제5제량조계속치료3례(제8조)균미발현DLT.전조미출현엄중간신공능손상,기타엄중반응포괄1례Ⅲ도빈혈,4례Ⅲ도구토,9례Ⅲ도체중하강.결론:TPF방안시치료만기비인암적안전유효방안,추천제량위태소제60mg/m~2 d1,DDP 60 mg/m~2 d1.5-FU 600 me/m~2 d1～5.
Background and Objective: PF regimen is the standard chemotherapy for advanced head and neck cancers including nasopharyngeal cancer. Recently PF has been found to enhance the tumor control by addition of taxotere. The purpose of this study was to evaluate the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of TPF neoadjuvant regimen [taxotere, cisplatin (DDP) and 5-fluorouracil (5-FU)]followed by radical radiotherapy in advanced nasopharyngeal carcinoma (NPC). Methods: Between December 2006 and May 2008, 41 patients with newly diagnosed UICC stage Ⅲ or Ⅳ advanced nasopharyngeal cancer were enrolled. There were 29 male and 12 female patients, with a median age of 47 years (range 29-60 years), and ECOG performance status ≤ 2.The initial dose was taxotere 40 mg/m~2 d1, DDP 40 mg/m~2 d1, and 5-FU 400 mg/m~2 d1-5. The treatment was repeated every 3 weeks for two cycles. Each dose of taxotere and DDP was increased by 5 mg/m~2 and 5-FU by 50 mg/m~2, respectively. The dose was escalated after six patients completed two cycles at the initial dose and DLT was assessed. Radiotherapy was started from the 5th week, with 68-72 Gy/34-36 fractions delivered to the nasopharynx and 60-66 Gy/30-33 fractions to the node-positive area.Results: Forty patients (79 cycles) were evaluated for toxicity and efficacy of the therapy. No DLT occurred at the dose levels 1-4. At dose level 5, three of six patients experienced DLT including grade Ⅲ/Ⅳ neutropenia lasting more than 1 week. Two of them also had grade Ⅲ mucositis, leading to the interruption of radiotherapy for more than 1 week. Three more new patients were retreated with the same dose (at dose level 6) under the G-CSF support, and no DLT occurred. Dose escalation continued to level 7, and DLT was found in all of the four patients, including three grade Ⅳ neutropenia, one of them had fever and pneumonitis; three grade Ⅲ diarrhea; and one grade Ⅲ mucositis lasting 10 days. Dose escalation was stopped and three more new patients were treated again at dose level 5 and no DLT was found. Other severe toxicities included grade Ⅲ anemia (1),grade Ⅲ vomiting (4), and grade Ⅲ weight loss (9). No severe hepatic and renal toxicities were found. Conclusions: TPF neoadjuvant chemotherapy is a safe and effective regimen in the treatment of advanced NPC, with recommended doses of taxotere 60 mg/m~2 dl, DDP 60 mg/m~2 d1, and 5-FU 600 mg/m~2 d1-5.